Registration Dossier
Registration Dossier
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EC number: 410-510-9 | CAS number: 86753-82-4
Endpoint summary
Administrative data
Description of key information
In a LLNA in mice as well as in a maximisation test in guinea pigs no sensitising potential was observed.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD 429 done under GLP with a well defined test substances of acceptable purity
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Vehicle:
- propylene glycol
- Concentration:
- 25%, 10%, or 5% w/w in propylene glycol
- No. of animals per dose:
- 5
- Parameter:
- SI
- Remarks on result:
- other: 0.76 (5%), 1.25 (10%, and 1.35 (25%)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 1869 (control), 1419 (5%), 2332 (10%), and 2523 (25%)
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The test item was considered to be a non-sensitiser under the conditions of the test.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study pre-dates accepability of LLNA
- Species:
- guinea pig
- Strain:
- other: Pirbright-White guinea pig
- Sex:
- female
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 25 %
- Day(s)/duration:
- 2
- Adequacy of induction:
- other: Treatment was done at the site of previous interdermal injections
- Route:
- intradermal
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 1 %
- Day(s)/duration:
- single injections
- Adequacy of induction:
- highest technically applicable concentration used
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 25 %
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- Challenge controls:
- 10 for treatment, 5 for control
- Positive control substance(s):
- no
- Positive control results:
- not specified, because of separate report, but positive results were obtained.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, none of ten animals of the treatment group showed a positive skin response after the challenge procedure.
Thus, the percentage of animals reacting positive is 0% ( below the threshold of 30 %).
Based on the results of this study the test item showed no evidence for sensitizing properties. - Executive summary:
Testing for sensitizing properties of the test item was performed in female guinea pigs according to the method of MAGNUSSON & KLIGMAN.
Intradermal induction was performed using 1 % of the test item in sesame oil. Dermal induction and challenge treatment were carried out with 25%
of the test item in sesame oil.
The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexyl cinnamic aldehyde for the maximization test
Based on the results of this study the test item sh
owed no evidence for sensitizing properties.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No classification
In a LLNA in mice no sensitising potential was observed
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